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    Medical Device Classification EU MDR

    Determination of the Medical Device Classification and the corresponding classification rule is the first step in the EU CE Marking process. Based on the class and the rule of the device, the technical file and the Notified Body application can be filed.

     

    According to the EU MDR 2017/745, Article 51, medical devices are classified into I, IIa, IIb, and III, considering their intended purposes and their inherent risks. The risk is incremental from class I to class III.

     

    EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR) both uses a rule based classification pattern for medical devices. in the new MDR there are now 22 rules in Annex VIII.

    Medical Device Classification

    Medical Device Classification with Examples!

    Class 1 - Low Risk

    Examples : Corrective glasses and frames, Manual wheelchairs

    Type of Certification : Self Certification / Self Declaration

    Class 1s Low Risk (Sterile)

    Examples : Personal protection kits, Sterile Urine Bags, etc.

    Type of Certification : Notified Body

    Class 1m Low Risk (Measuring Body attributes)

    Examples : Stethoscopes, Weighing Balance

    Type of Certification : Notified Body

    Class 1r Low Risk ( Reused Device)

    Examples : Surgical forceps ( All type of SS/Tit surgical equipment’s sterilized and reused by hospitals)

    Type of Certification : Notified Body

    Class IIa - Medium Risk

    Examples : Orthodontic wires, Surgical gloves, Lancets

    Type of Certification : Notified Body

    Class IIb - Medium to High Risk

    Examples : Orthopedic nails and plates, Intra-ocular lens, Incubators for babies

    Type of Certification : Notified Body

    Class III - High Risk

    Examples : Pacemakers, Prosthetic heart valves, Cardiovascular sutures, Brain spatulas, Drug-Device Combination products

     

    Type of Certification : Notified Body

    Medical Device Classification Rules!

    As per Annex VIII of the MDR, the Classification Rules are as follows:

     

    • Rules 1- 4: Non-invasive Devices
    • Rules 5 – 8: Invasive Devices
    • Rules 9 – 13: Active Devices
    • Rules 14 – 22: Special Rules

    I3CGLOBAL Scope

    I3CGLOBAL successfully completed 300+ CE Certifications worldwide by supporting manufactures with device classification of simple and complex device technologies for faster NB approval. We have offices in India, Europe and USA to help with classification and technical documentation.